Jee-Wook Leea,1, Hyung-Seop Hanb,1, Kyeong-Jin Hanc,1, Jimin Parkb, Hojeong Jeonb,d, Myoung-Ryul Okb, Hyun-Kwang Seokb,d, Jae-Pyoung Ahne, Kyung Eun Leee, Dong-Ho Leef, Seok-Jo Yangg, Sung-Youn Choh, Pil-Ryung Chaa, Hoon Kwona, Tae-Hyun Nami, Jee Hye Lo Hanh, Hyoung-Jin Rhob, Kang-Sik Leef,2, Yu-Chan Kimb,d,2, and Diego Mantovanij
aSchool of Advanced Materials Engineering, Kookmin University, Seoul 136-702, South Korea;
bCenter for Biomaterials, Korea Institute of Science & Technology, Seoul 136-650, South Korea;
cDepartment of Orthopaedic Surgery, Ajou University School of Medicine, Suwon 443-721, South Korea;
dDepartment of Bio-medical Engineering, University of Science & Technology, Daejeon 305-350, South Korea;
eAdvanced Analysis Center, Korea Institute of Science & Technology, Seoul 136-650, South Korea;
fDepartment of Orthopaedic Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul 138-736, South Korea;
gDepartment of Mechatronics Engineering, Chungnam National University, Daejeon 305-764, South Korea;
hR&D Center, U & I Corporation, Uijongbu 480-050, South Korea;
iSchool of Nano and Advanced Materials Engineering, Gyeongsang National University, Jinju 660-701, South Korea;
jLaboratory for Biomaterials and Bioengineering, Department of Mining, Laval University, Quebec City, QC, Canada G1V 0A6
Abstract
There has been a tremendous amount of research in the past decade to optimize the mechanical properties and degradation behavior of the biodegradable Mg alloy for orthopedic implant. Despite the feasibility of degrading implant, the lack of fundamental understanding about biocompatibility and underlying bone formation mechanism is currently limiting the use in clinical applications. Herein, we report the result of long-term clinical study and systematic investigation of bone formation mechanism of the biodegradable Mg-5wt%Ca-1wt%Zn alloy implant through simultaneous observation of changes in element composition and crystallinity within degrading interface at hierarchical levels. Controlled degradation of Mg-5wt%Ca-1wt%Zn alloy results in the formation of biomimicking calcification matrix at the degrading interface to initiate the bone formation process. This process facilitates early bone healing and allows the complete replacement of biodegradable Mg implant by the new bone within 1 y of implantation, as demonstrated in 53 cases of successful long-term clinical study.
biodegradable implant, bone formation, clinical application
1J.-W.L., H.-S.H., and K.-J.H. contributed equally to this work.
2To whom correspondence may be addressed.
Author contributions: J.-W.L., H.-S.H., H.-K.S., K.-S.L., and Y.-C.K. designed research; J.-W.L., H.-S.H., K.-J.H., J.P., H.J., M.-R.O., J.-P.A., D.-H.L., S.-J.Y., S.-Y.C., P.-R.C., H.K., T.-H.N., J.H.L.H., H.-J.R., K.-S.L., and Y.-C.K. performed research; S.-J.Y. and D.M. contributed new reagents/analytic tools; J.P., H.J., J.-P.A., K.E.L., P.-R.C., and D.M. analyzed data; K.-J.H. performed clinical trial; and J.-W.L., H.-S.H., and Y.-C.K. wrote the paper.